Description

Darunavir Impurity 11 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Darunavir. This compound is critical for ensuring the purity, safety, and efficacy of Darunavir-based drug products by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Darunavir API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure batches of Darunavir comply with stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity characterization data to health authorities like the FDA and EMA.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Darunavir.
• Research & Development: Aids in process chemistry research to understand and minimize the formation of this impurity during the synthesis of Darunavir.

Basic Information

Product Name	Darunavir Impurity 11
CAS No.	1932353-11-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Darunavir Related Compound 11; Darunavir EP Impurity J; Darunavir USP Impurity 11; (3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-yl (1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-1-benzyl-2-hydroxypropylcarbamate Impurity; Prezista Impurity 11; TMC-114 Impurity 11
EINECS	Contact for details

Quality Control

Our Darunavir Impurity 11 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, NMR, and MS. We ensure compliance with relevant pharmacopeial standards and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.